OBJECTIVES: It is important to obtain patient feedback to establish the content validity of patient-reported outcome (PRO) instruments. The objective of the study is to assess the content validity of an adapted Urticaria Activity Score (UAS) questionnaire for use in treatment trials with adolescent and adult chronic spontaneous urticaria (CSU) patients

METHODS: A cross-sectional qualitative study was initiated in November 2022 with adolescents aged 12-17 and adults ≥18 years with CSU. Study participants were recruited from US clinical sites and online CSU patient communities. A semi-structured hybrid concept elicitation (CE)/cognitive interviews (CI) were conducted. A patient guidance document for completing the UAS was also reviewed.

RESULTS: To-date, 11 of 30 interviews have been conducted (mean 43 ± 15 years, 100% female, 81% White, 64% Non-Hispanic, and 45% severe CSU symptoms).

In reviewing UAS item 1 (itch), participants understood “score” as “rate”. Participants liked the descriptions for mild, moderate, severe response options. For UAS item 2 (wheals [hives]), several participants were unfamiliar with the term “wheals” but understood “hives”. Participants found the UAS guidance document “helpful” and “easy to understand”. Participants appreciated that guidance was given for determining and counting hives in a 24-hour period. Suggestions for improving the guide included adding a picture to aid in counting hives.

Participants described CSU wheals (hives) as “raised skin,” “welts,” “red, pink, or skin-colored bumps,” “hot,” “inflamed,” “intensely itchy,” and “painful.” Itch severity and location of hives varied daily. Hives were reported as “all over body” to “3-4-inch patch on right lower leg”. CSU was reported to impact sleep and choice of clothing (to avoid touching hives or to cover-up skin).

CONCLUSIONS: Preliminary results support the content validity of an adapted UAS and provide valuable suggestions for improving the patient guidance for the UAS, which can be used in future treatment trials.